Details for New Drug Application (NDA): 073524

NDA 073524 describes EPITOL, which is a drug marketed by Teva and is included in two NDAs. It is available from two suppliers. Additional details are available on the EPITOL profile page.

The generic ingredient in EPITOL is carbamazepine. There are twenty-seven drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.

Summary for 073524

Tradename:	EPITOL
Applicant:	Teva
Ingredient:	carbamazepine
Patents:	0

Pharmacology for NDA: 073524

Mechanism of Action	Cytochrome P450 1A2 Inducers Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inducers Cytochrome P450 2C9 Inducers Cytochrome P450 3A4 Inducers
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Medical Subject Heading (MeSH) Categories for 073524

Analgesics, Non-Narcotic

Anticonvulsants

Antimanic Agents

Cytochrome P-450 CYP3A Inducers

Suppliers and Packaging for NDA: 073524

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EPITOL	carbamazepine	TABLET, CHEWABLE;ORAL	073524	ANDA	Teva Pharmaceuticals USA, Inc.	0093-0778	0093-0778-01	100 TABLET, CHEWABLE in 1 BOTTLE (0093-0778-01)
EPITOL	carbamazepine	TABLET, CHEWABLE;ORAL	073524	ANDA	Bryant Ranch Prepack	63629-9292	63629-9292-1	100 TABLET, CHEWABLE in 1 BOTTLE (63629-9292-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, CHEWABLE;ORAL			Strength	100MG
Approval Date:	Jul 29, 1992	TE:	AB	RLD:	No

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